MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE ED-580XT; DUODENOSCOPE AND ACCESSORIES

Model Number ED-580XT

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Bowel Burn (1756)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 fujifilm corporation was informed of an incident that occurred during an ercp procedure.Towards the end of the ercp procedure, a sphincterotomy was performed using the boston scientific truetome 44 sphincterotome and jagwire revolution guidewire, and erbe vio 300 d electrosurgical generator.The sphincterotomy was successful and when the scope was being pulled out to finish the procedure from papilla, they noticed what appeared to be a possible burn on the mucosal wall in the duodenum, opposite to the area where the sphincterotomy was performed.This possible burn was not visible during the sphincterotomy.It was only visible when scope was pulled back.The procedure was completed without any further difficulties.There is no death associated with event.

Manufacturer Narrative

Fujifilm is performing additional investigation to determine the root cause.A supplemental report will be submitted pending results of the investigation.Additionally, this is the sixth incident involving the ed-580xt scope and a non-fujifilm sphincterotome.All six incidents involved the same procedure at the same user facility.The previous five incidents were reported to the fda as 3001722928-2021-00021, 3001722928-2021-00008, 3001722928-2021-00004, 3001722928-2021-00024, and 3001722928-2021-00028.

Manufacturer Narrative

Fujifilm corporation conducted the root cause investigation that was concluded on (b)(6) 2022.During the investigation, it was identified that high-frequency devices were used with and without visualizing the proximal end of the wire on the endoscope monitor.As a result, the wire came in contact with the distal end metal part of the endoscope, causing a high-frequency current to flow through the distal end metal part.A burn can occur if the energized distal end metal part comes into contact with the mucosa.The relevant warnings are included in the ifu of ed-580xt and it is probable that user did not comply with these warnings.Unlike high-frequency devices, the distal end metal part has a large area, so it does not cut deeply and only superficial mucosal burns may occur.None of the seven (7) burns reported by fujifilm were serious injuries.Therefore, fujifilm believes that it will not lead to a serious injury.

Manufacturer Narrative

This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• Brand Name: FUJIFILM DUODENOSCOPE ED-580XT
• Type of Device: DUODENOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: safety officer ; 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 13062652
• MDR Text Key: 282704066
• Report Number: 3001722928-2021-00029
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED-580XT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other